Website Johnson & Johnson ltd
Post Name: Senior Executive, Commercial Quality
Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category: Professional
All Job Posting Locations: Mumbai, India
Job Description:
Overall purpose of job:
Responsible for the Quality Management System (QMS) establishment, maintenance & implementation at Johnson and Johnson Innovative Medicine (J&J IM) India and Pharm-dedicated 3PL Distribution Centers according to established Quality Manual to provide consistency in managing activities performed at multiple sites to meet customer expectations, applicable regulatory requirements, and Johnson & Johnson policies and standards
Key responsibilities:
1. GxP Compliance at 3PL Distribution Centers:
Follow adequate and appropriate quality management systems in collaboration with Deliver, where applicable, and followed at the 3PL Distribution Centers.
Ensure compliance to requirements for temperature sensitive products (Cold-Chain and cool chain products)
Support compliance related to J&J IM products handled by standalone/cross sector 3PL Distribution Centers in co-ordination with cross sector owning segment Commercial Quality (e.g., Product Returns, Field Actions, Market complaints, temperature excursions etc.)
Support during HA inspections at Pharm DC’s and reporting in Curve.
Provide support for investigations of the Quality Issues and monitor CAPA actions
Provide trainings on J&J IM India SOPs to DCs on need basis
Support Management of controlled substances
Escalate issues observed during handling of controlled substances
Responsible for providing quality oversights for facilities, utilities qualification and validation activities for CFAs and DCs
Support for preparing validation master plan and executing the same
2. Change Management:Ensure that all changes related to J&J products and critical changes at External Manufacturing Sites, 3PL warehouses and within J&J IM India are managed through change control system. The changes are assessed for its impact, executed & closed in compliance the regulatory & corporate requirements
Ensure appropriate internal and external change control systems are in place and are followed
Support execution of Change Control Review Board
3. Local Procedure Management:Prepare and update applicable LOC procedures in accordance with local GMP/GDP, BQM and J&J requirements through Tru Vault Document Management system
Ensure Tru Vault access is granted/ modified based on user’s need by admin access
4. Non-Conformance Management/CAPA ManagementEnsure that all non-conformances related to JNJ products, process or systems are suitably, scientifically and logically handled, documented, investigated for root cause, assessed for its impact on product quality and safety through appropriate system
Ensure that appropriate Corrective actions & Preventive actions are taken to mitigate the effect of nonconformance and recurrence in future as per process
5. Batch Release of Imported products sold in India & Quarantine ReleaseEnsure that the J&J IM SC Site products imported in India are released in ERP (SAP System) after satisfactory evaluation of the temperature data (for cold chain products), certificate of analysis, certificate of compliance and health authority test reports (wherever applicable)
Escalate the issues pertaining to the product, temperature excursion to the J&J IM SC Site Quality in event of any product quality or shipment issue via Trackwise system
6. Complaint ManagementReceive, acknowledge, log, investigate, assess the incoming Product Quality Complaints (PQC) and AEPQCs timely (India and affiliate- Srilanka, Bangladesh and Nepal countries)
Timely communication of complaints to the Manufacturing site and adverse events to the LSO for reconciliation, investigation and closure
Managing the market complaints via EZ reporter, Smartform & PQMS
Reconciliation of complaints weekly & monthly with PV
7. Training Management:Role based assessment of the SOPs, maintaining training curriculum as per identified roles and User Mapping for India LOC
Addition and Deletion of employees in specific user groups/ roles. Creation and obsoletion of curriculums assignation of training through applicable training management system
Ensure the appropriate training for all applicable stakeholder’s manual as well as through Training management system (Compliance wire and Summit)
Ensure, all assigned training completions is done within the due date by the stakeholders involved
8. Repackaging/RelabelingEnsure correct processes are followed during Repackaging & Relabeling at Repacker’s site
Approval of repackaging requests, Certificate of compliance and other related repackaging activities as per process.
Maintenance of the Image Master
Ensure approval of the label artworks of all the local and imported products is done to be compliant to regulatory requirements, license and other applicable rules
Provide quality oversight on serialization activities carried out on J&J IM India Products
Ensure Traceability and Verification of J&J IM India products on need basis.
9. Temperature Excursion ManagementImplement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products. Decision on usage or rejection of products in case of Temperature Excursion-India
10. Return Products handlingEnsure evaluation of all returned goods before rejecting or re-issuing
11. Product Recall/ Mock RecallSupport Product recall operation and related documentation.
12. Curve, React and Audit records ManagementSupport the creation of the curve, react and audit records with appropriate documentation in line with the good documentation practice requirements
Timely revision of the records and ensure closure abiding the associated timelines
13. Suppliers and Distributor ManagementSupport Quality Visits/ audit to suppliers and distributors
Prepare/ Review/ Share Visit/ Audit report and support for monitoring CAPA actions
Lead Supplier Audit/ Distributor Visits and track the Audit actions/ CAPA implementations
Trainings to Distributors for Handling Storage, Distribution and regulatory Compliance
Management of Approved Supplier List and associated documents
14. Internal Audits ManagementResponsible for management of internal audit schedule, execution and documentation as per process.
15. CAPA Review Board/ Local Change Control MeetingsResponsible for assessment of the data for subsequent CRB/ LCCB period
Organize CAPA Review Board meetings/ LCCB (on need basis) and Document the comments/ improvement points suggested by CRB/ LCCB and circulate MOM
Track the modification of QI/ CAPA/ COC as per comments received by CRB/ LCCB
16. Imported Product Testing from NABL Accredited LabResponsible for coordinating with contracted lab for testing within predefined timelines
Responsible for coordinating with supply chain for testing requirements and sample delivery
Responsible for coordinating with regulatory for ordering and maintaining stock of reference standards, impurities etc.
17. Field ActionsSupport execution of field actions
Coordinate with relevant stakeholders for field action execution and respective documentation
18. Data Management and Quality Record managementSupport Management of Quality Records as per the WWRIM schedule
Support activities related to destruction of records which have passed the timeline mentioned in WWRIM policies
19. Controlled Substance ManagementSupport Management of controlled substances
Escalate issues observed during handling of controlled substances
20. Other CollaborationCollaborate effectively with various internal partners like LSO, EQ, Finance, Supply chain, Deliver, SQ, MSAT, PES, Sales & Marketing, Legal, Brand Protection, PV, HR and MAF and other regional functions supporting complaint management like CCVs, Training Management. Collaborate external partners such as the Local Health Authorities, as applicable
Required Qualification and Core Competencies for the role:
The Candidate should meet the following knowledge, experience and skills:
Graduation or Post Graduation in Science – Preferably Pharmacy
At least 5 years ideally (5-7) Year’s experience in the Pharmaceutical or related industry, ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management and Regulatory Affairs, Where the position requires oversight of manufacturing / packaging / testing operations activities (internal or external), Manufacturing / QA operations experience is essential
Expert in Microsoft Office, Expert in investigations with knowledge on investigational tools, Proficient in Supplier audits, basic understanding of new technologies in pharma industry
Up-to-date knowledge of relevant pharmaceutical legislation and GMP / GDP
Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes
Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners
Full competency in local languages and English
Job location:
Job is based out of India Head Office; Johnson & Johnson Pvt. Ltd, Arena Space, Behind Majas Bus Depot, Off J.V. Link Road, Jogeshwari(E), Mumbai-400060
Requires 10-15% travel for audits/visits to Suppliers/ Distributors
